Post-Transplant GvHD Prophylaxis with PTCy, Bortezomib, and Abatacept

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1/2 interventional trial enrolling adults undergoing allogeneic hematopoietic stem cell transplantation from an HLA-matched sibling or 7/8 matched unrelated donor. In phase 1, the trial uses a 3+3 design to find the maximum tolerated dose of abatacept when combined with PTCy and bortezomib. Phase 2 comprises two single-arm, open-label cohorts (matched sibling and matched unrelated/mismatched strata) using an optimal 2-stage Simon design to evaluate efficacy at the phase I–defined dose. Participants receive standard conditioning, peripheral blood stem cells, and, for unrelated donors, rATG, along with investigational PTCy, bortezomib, and abatacept as GvHD prophylaxis. Outcomes include tolerability, safety, and signals of GvHD prevention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥14 years
* Karnofsky score ≥70%
* No evidence of progressive bacterial, viral, or fungal infection
* Creatinine clearance \>50 mL/min/1.72m2
* ALT and AST \<3 x the upper limit of normal
* Total bilirubin \<2 x the upper limit of normal (except for Gilbert's syndrome)
* Alkaline phosphatase ≤250 IU/L
* Left Ventricular Ejection Fraction (LVEF) \>45%
* Adjusted Carbon Monoxide Diffusing Capacity (DLCO) \>50%
* Negative HIV serology
* Negative pregnancy test: Confirmation per negative serum β-human chorionic gonadotropin (β-hCG)
* Willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

* Pregnant or nursing females or women of reproductive capability who are unwilling to completely abstain from heterosexual sex or practice 2 effective methods of contraception from start of conditioning through 90 days after the last dose of study drug. A woman of reproductive capability is one who has not undergone a hysterectomy (removal of the womb), has not had both ovaries removed, or has not been post-menopausal (stopped menstrual periods) for more than 24 months in a row.
* Male subjects who refuse to practice effective barrier contraception from the start of conditioning through a minimum of 90 days after the last dose of study drug, or completely abstain from heterosexual intercourse. This must be done even if they are surgically sterilized (i.e., post-vasectomy).
* Inability to provide informed consent.
* Patient had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see Appendix D), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
* Known allergies to any of the components of the investigational treatment regimen.
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma, an in-situ malignancy, or low-risk prostate cancer after curative therapy.
* Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.
* Prisoners
* Pregnant women

Where it's running

• Northwell Health
  New Hyde Park, New York, United States Recruiting

Study contacts

• Principal investigator: A. Samer Al-Homsi, MD, MBA — Northwell Health
• Study coordinator: Kelli Cole
• Email: kcole5@northwell.edu
• Phone: 516-734-8973

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Ruxolitinib maintenance after stem cell transplant for T‑cell lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.